NCT06314386

Brief Summary

This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape, South Africa to improve patient outcomes. The aims of this study are to:

  • Evaluate the effectiveness of SAIA-TB use in clinics on TB cascade outcomes for TB patients and with high-risk contacts
  • Determine the drivers of SAIA-TB implementation success or failure across clinics The investigators hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19,560

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Feb 2025Feb 2029

First Submitted

Initial submission to the registry

March 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

February 6, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

3.1 years

First QC Date

March 11, 2024

Last Update Submit

May 2, 2025

Conditions

TuberculosisTPTTB - Tuberculosis

Keywords

tuberculosis

Outcome Measures

Primary Outcomes (3)

  • TB Screening

    The proportion of individuals screened with WHO TB symptom screen in the target population

    18 months

  • Linkage to care for TB disease treatment

    The proportion of individuals initiating TB disease treatment among those with a positive diagnostic evaluation

    18 months

  • Linkage to care for TB preventive treatment

    The proportion of individuals initiating TB preventive treatment among those with a negative diagnostic evaluation and eligible for TPT

    18 months

Secondary Outcomes (4)

  • Successful TB Prevention Treatment (TPT) Outcome

    18 months

  • Successful TB Outcome

    18 months

  • TB Evaluation

    18 months

  • TB Diagnosis

    18 months

Study Arms (2)

Exposed

OTHER

Clinics are considered exposed after intensive SAIA-TB intervention, implementation phase, and maintenance phase.

Other: Systems Analysis and Improvement Approach for TB (SAIA-TB)

Unexposed

NO INTERVENTION

Clinics are considered unexposed prior to the initiation of SAIA-TB in their clinic

Interventions

Systems Analysis and Improvement Approach for TB (SAIA-TB)OTHER

The Systems Analysis and Improvement Approach for TB (SAIA-TB) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by clinic staff with support from study personnel in intervention clinics. Components of the intervention include TB cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally optimize TB screening, evaluation, diagnosis, TB preventive therapy and TB disease treatment initiation, successful treatment, and TB-free survival among the population at the intervention clinics.

Exposed

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Location in the municipalities of Dr. Beyers Naude, Blue Crane Route, Makana, Ndlambe, Sundays River Valley, Kou-Kamma, or Kouga within the Sarah Baartman district, Eastern Cape, South Africa
  • Within 2 hours' drive to Gqeberha, where the study office is located
  • Only one clinic per town/area/location to ensure a mix of rural, semi-rural, semi urban
  • Clinic capacity/Patient volume \> 700 total outpatient attendees per month (8,400 patients per year)
  • Staff size of at least 5 employees with a mixture of at least 2 professional nurses, 1 or 2 pharmacist/pharmacy technicians, at least 1 data capturer, a social worker, and multiple community health workers who are clinic-based or part of ward-based outreach teams.
  • Must have an acting Clinic Manager

You may not qualify if:

  • Clinic managers and/or staff are unwilling to participate
  • Aim 2:
  • years and older
  • Frontline clinical and/or managerial staff, district-level TB management
  • Ability to provide informed consent
  • Under age 18
  • Unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Addo Clinic

Addo, South Africa

Location

Lukhanyiso Clinic

Addo, South Africa

Location

Kwa-Nonqubela Clinic

Alexandria, South Africa

Location

Marselle Clinic

Boesmansriviermond, South Africa

Location

Masakhane Clinic

Hankey, South Africa

Location

Humansdorp Clinic

Humansdorp, South Africa

Location

Pellsrus Clinic

Jeffrey's Bay, South Africa

Location

Joubertina CHC

Joubertina, South Africa

Location

Louterwater Clinic

Joubertina, South Africa

Location

Twee Riviere Clinic

Joubertina, South Africa

Location

Kareedouw Clinic

Kareedouw, South Africa

Location

Kenton On Sea Clinic

Kenton on Sea, South Africa

Location

Kirkwood Clinic

Kirkwood, South Africa

Location

Moses Mabida Clinic

Kirkwood, South Africa

Location

Imizamo Yetho Clinic

Patensie, South Africa

Location

Nkwenkwezi Clinic

Port Alfred, South Africa

Location

Related Publications (1)

  • van de Water BJ, Brooks MB, Matji R, Ncanywa B, Dikgale F, Abuelezam NN, Mzileni B, Nokwe M, Moko S, Mvusi L, Loveday M, Gimbel S. Systems analysis and improvement approach to optimize tuberculosis (SAIA-TB) screening, treatment, and prevention in South Africa: a stepped-wedge cluster randomized trial. Implement Sci Commun. 2024 Apr 16;5(1):40. doi: 10.1186/s43058-024-00582-z.

    PMID: 38627799DERIVED

MeSH Terms

Conditions

TuberculosisLatent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Study Officials

  • Brittney J van de Water, PhD

    Boston College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped Wedge Crossover Cluster
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 18, 2024

Study Start

February 6, 2025

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

February 28, 2029

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

ZA(16)